Kornimate/medical-research-clean huggingface dataset:
treatment of uc with novel therapeutics

Conditions: Ulcerative Colitis Mild; Ulcerative Colitis

Summary: this study is a clinical trial being done to investigate the efficacy of drug brs201 as a treatment in patients with active mild ulcerative colitis. participation in this study will take 12 weeks long and the study is structured as a crossover study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. participation may also involve receiving an iv dose of the medication. the study will require participants to attend 7 study visits, all of which will be conducted at a study site. participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study.


Eligibility criteria:
inclusion criteria: * ability to give consent * patients with a confirmed diagnosis of uc for \> 3 months * history of ≥ 15 cm of colonic involvement as confirmed by colonoscopy * disease activity based on calprotectin \> 200 * allowed medications: mesalamine and sulfasalazine * patients with primary sclerosing cholangitis are eligible to enroll exclusion criteria: * history of uncontrolled hypertension with systolic bp \> 140 and systolic bp \> 90 * chronic kidney disease as defined by gfr \<55ml/min * impaired hepatic function (transaminases elevated \> 2.5 x uln) unless due to psc * evidence of c. difficile (negative test result within 1 month is acceptable) * infectious colitis or drug induced colitis * crohn's disease or indeterminate colitis * decompensated liver disease * patients who are pregnant or breastfeeding * use of rectal therapies * patients who have a confirmed malignancy or cancer within 5 years * congenital or acquired immunodeficiencies * other comorbidities including: diabetes mellitus, systemic lupus * high likelihood of colectomy in the next 2 months * participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial * patients with a history or risk of cardiovascular conditions, including arrhythmia, long qt syndrome, congestive heart failure, stroke, or coronary artery disease * prohibited medications: vitamin c, prednisone, immune modulators (including but not limited to azathioprine, 6-mercaptopurine, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10, interleukin-11, and omvoh or mirikizumab-mrkz) and biologics within the past six weeks including anti-tnf agents within the past six weeks, vedolizumab within the past six weeks, ustekinumab risankizumab), a jaki (tofacitinib or upadacitinib), or velsipity (etrasimod) within the past 6 weeks. (the aim is to treat people who are having disease activity and just on mesalamine.)
evaluation of a smartphone application, gocheckkids™ as a photo screening tool in a pediatric population

Conditions: Amblyopia

Summary: objective: prospective evaluation of gocheckkids™, a smartphone application ('app') as a photo screening device in a pediatric population to detect amblyopia risk factors (arfs) method: photorefraction images are captured using up to 4 different devices with gocheckkids™ app and patients are evaluated with cycloplegic refraction.


Eligibility criteria:
inclusion criteria: * age 12 months to 6 years inclusive. * informed consent given by parent or legal guardian. exclusion criteria: * history of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement

Keywords: myopia hyperopia anisometropia amblyopia risk factors risk factors smartphone application (app) photoscreening vision screening mobile vision screening
pilot study comparing ventilation modes during cpr with mechanical compression device.

Conditions: Cardiopulmonary Resuscitation

Summary: comparison of three ventilation modes (volume controlled, bipap and cpap) during cardiopulmonary re-suscitation with a mechanical compression device in the emergency room. primary aim is to assess mean ventilation volume in the first 15 minutes after randomization.

mechanical compression devices are applied to grant continuous chest compressions and consequently blood flow during cpr (cardiopulmonary rescuscitation). current guidelines, however, are lacking guidance of the optimal ventilation strategy in such scenarios. this may lead to lung injuries caused by high pressure levels in the chest while applying compression and ventilation simultaneously or hypoventilation. consequently, this pilot study assesses iwhich ventilation mode is optimal. patients will be assigned randomly to one of the three ventilation modes (volume controlled, bipap-asb, cpap). ventilation parameters will be continuously monitored for 15 minutes while blood gas analyses are taken as well. further secondary outcome parameters will be assessed, e.g. hospital mortality.

Eligibility criteria:
inclusion criteria: * on-going out of hospital cpr in the emergency room * tracheal intubated * use of mechanical chest compression device exclusion criteria: * if the treating team assumes that cpr will be ceased within the next 15 minutes

Keywords: respiration, artificial advanced cardiac life support heart massage emergency service, hospital
real-life study of how to intensify treatment with xolair (omalizumab) in chronic spontaneous urticaria

Conditions: Spontaneous Urticaria, Chronic

Summary: this is an observational study whose main objective is to estimate the frequency of patients benefiting from an intensification of aom treatment at 3 months.


Eligibility criteria:
inclusion criteria: * patient having expressed non-opposition * affiliation to a social protection scheme (beneficiary or entitled person) * decision by the investigator to initiate, independently of the study, an aom treatment for spontaneous chronic urticaria that may or may not be associated with an inducible component. exclusion criteria: * patients \< 18 years of age * patient who had previously received aom treatment prior to the inclusion visit * patients under guardianship or curatorship * pregnant or breastfeeding woman
computed tomographic evaluation of atherosclerotic determinants of myocardial ischemia

Conditions: Myocardial Ischemia

Summary: the study seeks to determine the accuracy of using anatomic and physiologic information measurable by computed tomography features of stenosis, plaque, fractional flow reserve-ct and to compare this measure to stress testing for the detection of myocardial ischemia against the gold standard of cardiac catheterization with fractional flow reserve. the hypothesis of this proposal is that integrating anatomic plaque features with physiologic fractional flow reserve-ct will optimize identification of coronary lesions that are ischemia-causing by computed tomography .

the credence trial will be a prospective multicenter cross-sectional study of 618 individuals (n=309 \[derivation cohort\]; n=309 \[validation cohort\]) who will undergo stress test, computed tomography, cardiac catheterization and fractional flow reserve. for the purposes of the study, either stress test or computed tomography will have been performed for clinical purposes, with the other test being performed as part of trial procedure. study analyses will focus on the diagnostic performance of the information derived by stress test versus computed tomography against an invasive gold standard of cardiac catheterization and fractional flow reserve for an endpoint of vessel territory-specific ischemia. in keeping with prior studies, vessel territories will be comprised of the left anterior descending artery (and diagonal branches), the left circumflex artery (and obtuse marginal branches) and the right coronary artery (and posterolateral branch and posterior descending artery). to date, the relative performance of traditional stress imaging testing compared to the entirety of information proffered by ct has not been assessed compared to an unbiased gold standard. the study proposed herein will directly address this unmet need.

Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. scheduled to undergo clinically-indicated non-emergent invasive coronary angiography exclusion criteria: 1. known cad (myocardial infarction \[mi\], percutaneous coronary interventions \[pcis\], coronary artery bypass graft \[cabg\],) 2. hemodynamic instability 3. inability to provide written informed consent 4. concomitant participation in another clinical trial in which subject is subject to investigational drug or device 5. pregnant state 6. absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) 7. serum creatinine ≥1.7 mg/dl or glomerular filtration rate \<30 ml/min 8. baseline irregular heart rhythm (e.g., atrial fibrillation, etc.) 9. heart rate ≥100 beats per minute 10. systolic blood pressure ≤90 mm hg 11. contraindications to β blockers or nitroglycerin or adenosine 12. bmi \>40 kg/m2
patient-centered outcomes after permanent female sterilization procedure(pops trial)

Conditions: Sterility, Female

Summary: the purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.


Eligibility criteria:
inclusion criteria: * premenopausal women scheduled to undergo an elective sterilization surgery regardless of parity * non-prolapsed uterus * patients should able to provide written consent exclusion criteria: * women who have relative contra-indication to vaginal peritoneal access such as: history of rectal surgery, suspected recto-vaginal endometriosis based on clinical history and examination, suspected malignancy, pelvic inflammatory disease, active lower genital tract infection, virginity or pregnancy * postpartum (immediate) tubal sterilization * tubal sterilization during a cesarean section

Keywords: laparoscopy quality of recovery vaginal natural orifice transluminal endoscopic surgery
immune response in adults to prep and simulated booster pep with a new cprv

Conditions: Efficacy of the New CPRV

Summary: pre exposure rabies vaccination with a new chromatographically purified vero-cell rabies vaccine(speeda) is as effective as purified vero-cell rabies vaccine. after the pre exposure rabies vaccination with a new chromatographically purified vero-cell rabies vaccine(speeda), the rabies neutralizing antibodies in all patients on day 42 are 0.5 iu/ml or more. and simulated post-exposure rabies booster vaccination with a new chromatographically purified vero-cell rabies vaccine(speeda) is as effective as purified vero-cell rabies vaccine. after the simulated post-exposure rabies booster vaccination with a new chromatographically purified vero-cell rabies vaccine(speeda), the rabies neutralizing antibodies in all patients on day 14 after the booster are 0.5 iu/ml or more.

pre-exposure vaccination will be done according to standard protocol. participants will be injected with one dose on day 0, 7 and 28. blood samples will be taken on day 0, 28 and 42 after the first vaccination dose. 360 days later, participants will receive simulated post-exposure rabies booster vaccination one dose on day 0 and 3. blood samples will be taken again on day 0(360 days) and 14(374 days) after the booster vaccination. rabies neutralizing antibody levels will be measured by rapid fluorescent focus inhibition test(rffit). and the levels of 0.5 iu/ml or more is considered acceptable protective level. for statistical analysis, percentage of subjects achieving seroconversion (defined as rnab ≥ 0.5 iu/ ml) are determine at each sampling time. the average of the titer used in this study is geometric mean titer(gmt). 95 percent confidence interval(95% ci) of the gmt will be calculated for each study group from individual measurements of serum rabies antibody levels at each sampling time. one-way anova would be used to calculated the significance of the difference between the gmt of three groups, speeda® intradermal injection, speeda® intramuscular injection and pvrv intramuscular injection. the primary criterion for this comparison are the rabies antibody value on day 42 (2 weeks after the third vaccine dose of pre-exposure vaccination) and on day 374(2 weeks after the first vaccine dose of booster vaccination). results will be deemed statistically significant at p \< 0.05. safety data (immediate, local and systemic reactions) were summarized as numbers and percentages.

Eligibility criteria:
inclusion criteria: * healthy * can visit according to the protocol exclusion criteria: * fever * acute illness * history of rabies vaccination * allergic to the vaccines' component * immunosuppressive conditions such as hiv infection, transplantation, chronic renal failure, received steroid or immunosuppressive drugs and anti-malarial drugs within previous two months or any blood products within previous three months * female participant must not be pregnant * all female participant must have urine pregnancy test negative prior to participate the study

Keywords: cprv speeda intradermal pre-exposure booster
the impact of qigong on quality of life and sleep disturbance in head and neck patients undergoing radiotherapy

Conditions: Head and Neck Cancer

Summary: this study aimed to observe how a six week qigong program influence patients with head and neck cancer during active radiotherapy treatment course. the quality of life, sleep dysfunction or depression and shoulder and neck function will be accessed by questionnaire, and ans function will be objectively investigated using heart rate variability measurement.

the incidence of head and neck cancers is the 6th in taiwan, and head and neck cancers are the 5th leading cause of cancer death, causing approximately 2000 death in 2010. head and neck cancers patients usually require multimodality treatments, including surgery, chemotherapy and radiotherapy. these treatments can cause functional deterioration and worsened quality of life during or after the treatment, and bring tremendous effects on patient's life. when radiotherapy is indicated, it requires 6 to 7 weeks treatment, and most patients suffered from different degrees of mucositis, dermatitis, xerostomia and neck and shoulder tightness during radiotherapy. how to improve quality of life for these patients during radiotherapy is an important task. qigong is a mind-body exercise or therapy; it can improve quality of life, such as fatigue, sleep dysfunction and depression through regulation of breath and simple physical exercise. some found that the qigong can decrease inflammation and show some impact on accommodation of ans in cancer patients. most studies focus on how qigong effect on cancer survivors, however, this study is aimed to observe how a six week qigong program influence patients with head and neck cancer during active radiotherapy treatment course. the quality of life, sleep dysfunction or depression and shoulder and neck function will be accessed by questionnaire, and ans function will be objectively investigated using heart rate variability measurement.

Eligibility criteria:
inclusion criteria: - clinical diagnosis of head and neck squamous cell carcinoma, subsites including nasopharyngeal cancer, oropharyngeal cancer, oral cancer, hypopharyngeal cancer and laryngeal cancer performance status ecog 0-1 physically able to participate in the qigong program exclusion criteria: - previous radiotherapy to head and neck region patients who refused to sign the informed consents patients who took antihypertensive drugs, sedatives, or antiarrhythmic drugs
fluvastatin in the therapy of acute coronary syndrome

Conditions: Coronary Disease; Myocardial Infarction

Summary: this study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed shortly after or immediately when the coronary event occurs.


Eligibility criteria:
inclusion criteria: * acute coronary syndrome * adults, 18 years and older exclusion criteria: * history of lipid lowering therapy less than 30 days before index event * pregnancy and nursing * subject younger than 18 years other inclusion and exclusion criteria may apply.

Keywords: coronary disease myocardial infarction statins
association of functional dyspepsia symptom diary score and other scores related to functional dyspepsia and its severity

Conditions: Functional Dyspepsia

Summary: functional dyspepsia (fd) is a common functional gastrointestinal disease. several patient-reported outcome questionnaires have been established to evaluate the severity of fd, including dyspepsia symptom severity index (dssi), nepean dyspepsia index (ndi), and short-form nepean dyspepsia index (sf-ndi). functional dyspepsia symptom diary (fdsd) is a newly symptom-focused patients-reported outcome measure raised by the patient-reported outcome consortium's functional dyspepsia working group. the association of the novel fdsd and other scores-related to fd has not been fully investigated. furthermore, the severity of fd is varied among different patients. it remains unclear how the moderate and severe fd can be defined by the fdsd.


Eligibility criteria:
inclusion criteria: * 1. 18-70 years old * 2. patients who met the rome iv diagnostic criteria of fd * 3. normal upper endoscopy and abdominal ultrasonography within one year. exclusion criteria: * 1, patients with local or systemic diseases which may cause dyspeptic symptoms: 1. known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc. 2. known acute or chronic diseases of liver or kidney 3. obvious hematological abnormality, or endocrine and metabolic diseases 4. suspected incomplete or complete bowel obstruction 5. known malignancy 6. other conditions which may be associated with dyspeptic symptoms (such as nsaids associated dyspepsia) * 2, pregnancy * 3, inability to give informed consent
innate immunity in eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: the main aim of this study is to assess the expression of innate lymphoid cells in the esophageal mucosa of children with eosinophilic esophagitis (eoe) and in control subjects

children (aged 1 to 18 years) presenting with symptoms suggestive of eoe and requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa in order to confirm or exclude the diagnosis of eoe will be included. children paired for age in whom an endoscopy performed to explore symptoms of eoe revealed another condition (peptic oesophagitis, achalasia), or children paired for age in whom an endoscopy with biopsies has been performed to explore chronic abdominal or epigastric pain or suspected chronic inflammatory bowel disease, will be include as control subjects. the endoscopy will be performed under general anaesthesia using a flexible endoscope with an external diameter of between 4.9 and 9.2 mm, depending on the size of the child. in line with the guidelines, eight biopsies will be collected from the proximal, median and distal oesophagus for the routine analysis of esophageal remodelling and inflammation. three of these biopsies will be used in the context of this study to analyse innate immune cells using flow cytometry and to determine the profile of cytokine expression. two biopsies will be placed in sterile, 0.5 ml nunc tubes containing a storage buffer (macs® tissue storage solution) and then stored in ice until the extraction of cells for cytometric analysis. the third specimen will be placed in a sterile tube and frozen immediately in liquid nitrogen for analyses of the esophageal microbiome. ilc1, 2 and 3 and their sub-types will be identified by means of structural criteria (size and granularity) and differential membrane and intracellular labelling using the specific markers shown below. all acquisitions and analyses will be achieved using a 13-colour novocyte cytometer (aacea) and its associated software (novoaxpresstm), which are available in the laboratory.

Eligibility criteria:
inclusion criteria: * children 1-18 years * presenting with symptoms suggestive of eoe * requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa in order to confirm or exclude the diagnosis * children paired for age in whom an endoscopy performed to explore symptoms of eoe revealed another condition (peptic oesophagitis, achalasia), or children paired for age in whom an endoscopy with biopsies has been performed to explore chronic abdominal or epigastric pain or suspected chronic inflammatory bowel disease, will be include as control subjects exclusion criteria: * immune deficiency * auto immune diseases

Keywords: eosinophilic esophagitis children innate immunity
a comparative trial focusing on injections with the medical device dv3316 pen-injector versus flexpen®

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to compare injections with the medical device dv3316 pen-injector versus flexpen®.


Eligibility criteria:
inclusion criteria: * male or female aged 18-74 years (both included) at the time of signing informed consent * t1dm (type 1 diabetes mellitus) or t2dm (type 2 diabetes mellitus) (as diagnosed clinically) at least 12 months prior to screening * daily self-injection(s) with anti-diabetic drug (insulin or glucagon-like peptide-1 (glp- 1) analogues) in pen-injector or vial/syringe for at least 12 months * caucasians * body mass index (bmi) at least 18.5 kg/m\^2 exclusion criteria: * known or suspected hypersensitivity to test placebo solution incl. m-cresol and phenol or related products (placebo) * female who is pregnant,, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) * known urticaria factitive or abnormal reactions to mechanical trauma * haemophilia and any diseases affecting blood coagulation * anti-coagulant or inhibitors of platelet aggregation treatment on the day of the visit * intake of any pain-relieving or analgesic drugs on the day of the site visit * skin diseases and infections of the skin in the injection site areas (abdomen and thighs) * lipodystrophia in the injection site areas (abdomen and thighs)
study on the application of convenient foot-control exhaust method in endoscopic thyroidectomy

Conditions: Thyroid Cancer; Papillary Thyroid Carcinoma; Thyroidectomy; Endoscopy

Summary: endoscopic thyroidectomy developed rapidly in recent years, and the most popular surgical approach was endoscopic thyroidectomy by bilateral areola approach, but some operative steps was required optimization. one of the most annoying problem was the smog blurring endoscopic lens during surgery. the researcher summarized a set of convenient foot-control exhaust method and carried out this prospective study.

the patients with papillary thyroid microcarcinoma were included according to the inclusive criteria and randomly divided them into two groups (foot-control exhaust group and direct exhaust group). the foot-control exhaust group used the foot-control exhaust method by the way of adjustable pressure to intermittent exhaust, while direct exhaust group exhaust through the trocar hole. comparison of operation time, times of wiping the endoscopic lens, volume of postoperative drainage, and number of identified parathyroid gland between two groups.

Eligibility criteria:
inclusion criteria: 1. patients with maximum tumor diameter ≤1 cm; 2. patients without lateral neck lymph node metastases; 3. patients without distant metastases; 4. patients who only needed unilateral surgery following the guidelines; 5. patients with strong cosmetic requirement. exclusion criteria: 1. patients with maximum tumor diameter \>1 cm; 2. patients who needed complement total thyroidectomy according to the guidelines, including tumor extrathyroidal extension as well as large amount of neck lymph node metastases and distant metastases; 3. patients without cosmetic requirements.

Keywords: endoscopy thyroidectomy thyroid cancer